Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MEN Count)

This study is ongoing, but not recruiting participants.

Sponsor:

University of California, San Diego

ClinicalTrials.gov Identifier:

NCT01694121

First Posted: September 26, 2012

Last Update Posted: November 24, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to evaluate the effectiveness of the MEN Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. MEN Count was developed and pilot tested using a CBPR approach via funding from an NIH R21, in Boston, MA. A more larger scale, two-armed quasi-experimental controlled trial design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic and other community-recruitment methods in Washington, DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design will be conducted in which participants will receive either MEN Count or an attention comparison program similar to MEN Count in structure. We will assess program impact on reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted to ensure high quality program adherence and delivery, as well as to support program replication should the model prove effective.

An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.

Behavioral: Comparison

general health intervention for men, not inclusive of HIV or relationship health

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 40 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694121